Fluid OverloadNCT01438502
"The Effect of Reduced Fluid Load After Cardiac Surgery"
An observational study of Fluid Overload and Organ Edema, run by Haukeland University Hospital.
Trial summary
The purpose of this study is to verify that an infusion of hypertonic saline/colloids during cardio-pulmonary-bypass will reduce fluid overload and organ edema for cardiac patients with expected long-CPB-time. Expected beneficial effects are improved organ function for heart and lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload, Organ Edema, Organ Function
- What is being tested?
- HyperHAES® (hypertonic saline/HES)
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for combination surgery, both elective coronary bypass and valve surgery, with expected long CPB-time, and who after orally and written information agrees to participate in the study.
Who cannot join
- Age less than 18 years
- Serum-Sodium higher than 145 mmol/l
- Hematocrit less than 30 %
- Estimated GFR less than 60
- BMI more than 30 or BMI less than 18
About this study
Official title: "The Impact of Hypertonic Saline/ Colloids Infusion During Cardio-pulmonary-bypass in Patients Expected Long CPB-time"
The purpose of this study is to verify that an infusion of hypertonic saline/colloids during cardio-pulmonary-bypass will reduce fluid overload and organ edema for cardiac patients with expected long-CPB-time.
Expected beneficial effects are improved organ function for heart and lungs.
Read the detailed description
Fluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been reported to impair both systolic and diastolic function. An association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients.
Our group has experience with the use of hypertonic saline/colloids in several experimental studies (pigs). In these animal studies we have used hypertonic saline/colloids both as an infusion during CPB or as an additive to CPB-prime. Both administration methods resulted in significant reduction in fluid loading due to better intravascular volume preservation.
One clinical study from our group observed reduced fluid load and an improved cardiac index when an infusion of hypertonic saline/colloids was used during cardiac surgery. Patients included in this study had a normal left ventricular function and no co-morbidity.
The planned study includes patients with combination procedures, both aorta coronary bypass and valve implantation, and expected long CPB-time.Time spent on CPB is a individual risk factor negatively associated with increased mortality and morbidity. The investigators believe high-risk patients will have even more benefit of reduced fluid loading. Their tolerance for hypovolemia is lower and the incidence for hemodynamic instability first hours postoperatively is greater.
The patients will be randomized to receive either a continuous infusion of hypertonic saline/colloids or acetated Ringer's solution during CPB. Accurate accounts of fluid additions, blood loss and diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.
Preoperative and postoperative echo cor will be performed.
- Conditions
- Fluid Overload, Organ Edema, Organ Function
- Being tested
- HyperHAES® (hypertonic saline/HES)
- Keywords
- cardiac surgery, cardio-pulmonary-bypass
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperHAES® (hypertonic saline/HES)Drug
Also called HyperHAES® (7.2 % NaCl/ 6 % hydroxyethyl-stivelse (200/0.5)
After arrival to the operating theatre both study groups will receive an infusion of acetated Ringers solution 4 ml/kg/hour. Additionally both groups for 4 hours will receive 1 ml/kg/hour of a blinded solution. This solution will be either acetated Ringers solution or HyperHAES® (7.2 % NaCl/ 6 % hydroxyethyl-starch (200/0.5)).
| Study group | Role | What they receive |
|---|---|---|
| HyperHAES | Not described Receives: Drug: HyperHAES® (hypertonic saline/HES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of organ edema and improved organ function
As a target for effect the investigators have chosen to study improvements for organ function. Indexed values for cardiac output (CI) measured by the PICCO system will be a parameter for heart function, and lung function will be measured by EVLWI (extravascular lung water index), paO2/FiO2 -ratio and time spent in respirator. Additionally a strict account for fluid balance will be kept.
Measured: 24-hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
Why it stopped: Changes in staff resulted in logistic difficulties to perform the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438502
- Sponsor's protocol ID
- 2011/491
- Status last verified
- Nov 2013
- First submitted
- 19 Sep 2011
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Impact of Hypertonic Saline/ Colloids Infusion During Cardio-pulmonary-bypass in Patients Expected Long CPB-time"
- ClinicalTrials.gov ID
- NCT01438502
- Acronym / sponsor ID
- 2011/491
- Conditions
- Fluid Overload, Organ Edema, Organ Function
- Keywords
- cardiac surgery, cardio-pulmonary-bypass
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Changes in staff resulted in logistic difficulties to perform the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- First posted
- 22 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to verify that an infusion of hypertonic saline/colloids during cardio-pulmonary-bypass will reduce fluid overload and organ edema for cardiac patients with expected long-CPB-time.
Expected beneficial effects are improved organ function for heart and lungs.
Detailed description
Fluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been reported to impair both systolic and diastolic function. An association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients.
Our group has experience with the use of hypertonic saline/colloids in several experimental studies (pigs). In these animal studies we have used hypertonic saline/colloids both as an infusion during CPB or as an additive to CPB-prime. Both administration methods resulted in significant reduction in fluid loading due to better intravascular volume preservation.
One clinical study from our group observed reduced fluid load and an improved cardiac index when an infusion of hypertonic saline/colloids was used during cardiac surgery. Patients included in this study had a normal left ventricular function and no co-morbidity.
The planned study includes patients with combination procedures, both aorta coronary bypass and valve implantation, and expected long CPB-time.Time spent on CPB is a individual risk factor negatively associated with increased mortality and morbidity. The investigators believe high-risk patients will have even more benefit of reduced fluid loading. Their tolerance for hypovolemia is lower and the incidence for hemodynamic instability first hours postoperatively is greater.
The patients will be randomized to receive either a continuous infusion of hypertonic saline/colloids or acetated Ringer's solution during CPB. Accurate accounts of fluid additions, blood loss and diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.
Preoperative and postoperative echo cor will be performed.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HyperHAES | – | Drug: HyperHAES® (hypertonic saline/HES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for combination surgery, both elective coronary bypass and valve surgery, with expected long CPB-time, and who after orally and written information agrees to participate in the study.
Key exclusion criteria (5 listed)
- Age less than 18 years
- Serum-Sodium higher than 145 mmol/l
- Hematocrit less than 30 %
- Estimated GFR less than 60
- BMI more than 30 or BMI less than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperHAES® (hypertonic saline/HES)Also: HyperHAES® (7.2 % NaCl/ 6 % hydroxyethyl-stivelse (200/0.5)After arrival to the operating theatre both study groups will receive an infusion of acetated Ringers solution 4 ml/kg/hour. Additionally both groups for 4 hours will receive 1 ml/kg/hour of a blinded solution. This solution will be either acetated Ringers solution or HyperHAES® (7.2 % NaCl/ 6 % hydroxyethyl-starch (200/0.5)). | Drug | HyperHAES |
Primary outcome
Reduction of organ edema and improved organ function
Time frame: 24-hours postoperatively
As a target for effect the investigators have chosen to study improvements for organ function. Indexed values for cardiac output (CI) measured by the PICCO system will be a parameter for heart function, and lung function will be measured by EVLWI (extravascular lung water index), paO2/FiO2 -ratio and time spent in respirator. Additionally a strict account for fluid balance will be kept.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Overload and Organ Edema, run by Haukeland University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of organ edema and improved organ function (time frame: 24-hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.